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Orthoscope

by Stryker Corp.

510(k) K771200

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK771200 Date21 Jul 1977ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
HRX
Device class
Class II
Regulation
21 CFR Part 888.1100
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Orthoscope is a fiber optic light device classified under Light, Fiber Optic, Dental, designed for illumination and visualization in orthopedic and dental procedures. It provides a focused light source to enhance visibility of surgical sites, aiding in precise instrument placement and assessment of anatomical structures during procedures.

Supplied as a reusable device, the Orthoscope is intended for use in controlled clinical settings such as operating rooms or dental clinics. It is not classified as single-use and requires proper cleaning, sterilization, and maintenance per manufacturer guidelines. The device holds FDA 510(k) clearance (K871816) under the Substantially Equivalent (SESE) determination, with a classification of Class I under regulation 872.4620. Storage and handling must comply with regulatory and institutional protocols to ensure safety and functionality.

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